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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SOLIA S 53; PACING LEAD

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BIOTRONIK SE & CO. KG SOLIA S 53; PACING LEAD Back to Search Results
Model Number 377177
Device Problems Intermittent Capture (1080); Pacing Intermittently (1443); Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2022
Event Type  malfunction  
Event Description
This lead was explanted due to bipolar rv lead failure, with low out of range impedance on home monitoring the morning after implant.With bipolar programming the rv impedance measured less than 100 ohms, capture was intermittent at 7.5 v at 1.0 ms, and there was no sensing.Testing in unipolar revealed no issues and so the lead was permanently programmed to unipolar pacing and sensing, but noise was present which resulted in underpacing.At (b)(6) 2023 revision, bipolar impedance did normalize after suture tie downs were removed, but the decision was made to replace the lead anyway due to the noise.
 
Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The analysis showed that the lead body was found squeezed and damaged 9.5 cm distal to the is-1 connector pin, which is assumed to be the root cause of the reported electrical issues.The damage most likely resulted from a tight suture sleeve during the implantation procedure.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.
 
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Brand Name
SOLIA S 53
Type of Device
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key16253063
MDR Text Key308258480
Report Number1028232-2023-00424
Device Sequence Number1
Product Code NVN
UDI-Device Identifier04035479118266
UDI-Public(01)04035479118266(17)240930
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number377177
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age74 YR
Patient SexMale
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